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Adjunctive Methylene blue in Septic shock patients receiving low-dose vasopressors: A randomized controlled trial

Adjunctive Methylene blue in Septic shock patients receiving low-dose vasopressors: A randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250827006
Enrollment
48
Registered
2025-08-27
Start date
2025-09-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic shock patients receiving low-dose vasopressors Septic shock Methylene blue

Interventions

Methylene blue 100 mg in 100 mL of 5% dextrose in water, administered via continuous intravenous infusion over 6 hours per day, until vasopressors could be discontinued for 24 hours, with a total trea
Active Comparator Drug,Placebo Comparator Drug
Methylene blue,5% dextrose in water

Sponsors

Phramongkutklao hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with septic shock who received high-dose vasopressors prior to study enrollment equivalent to norepinephrine greater than or equal to 0.05 mcg/kg/min

Exclusion criteria

Exclusion criteria: 1. Patients with septic shock who received high-dose vasopressors prior to study enrollment equivalent to norepinephrine greater than or equal to 0.25 mcg/kg/min 2. Patients with concurrent shock of other etiologies, including hemorrhagic shock, obstructive shock, or cardiogenic shock 3. Patients with a history of allergy to methylene blue 4. Patients with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency, a family history of G6PD deficiency, or a G6PD enzyme level of less than 197 IU/100 mL of red blood cells 5. Patients receiving selective serotonin reuptake inhibitors (SSRIs) 6. Pregnant patients 6. Patients with burn injuries

Design outcomes

Primary

MeasureTime frame
Time to vasopressor discontinuation Time to vasopressor discontinuation Hours / Continuous hemodynamic monitoring, recorded from time of enrollment until vasopressor discontinuation.

Secondary

MeasureTime frame
MAP at 1, 6, 12, 24, 48, 72 hours at 1, 6, 12, 24, 48, 72 hours after start intervention mmHg / Continuous hemodynamic monitoring,Serum lactate level at 1, 6, 12, 24, 48, 72 hours at 1, 6, 12, 24, 48, 72 hours after start intervention mmol/L / Blood test,Maximum dose of vasopressor at 72 hours after start intervention mcg/kg/min / Medical record,Cumulative norepinephrine dose at 72 hours after start intervention mcg/kg/min / Medical record,Vasopressor-free day at 7 days after start intervention day / Medical record,Hydrocortisone use at 72 hours after start intervention percent / Medical record,Cumulative fluid intake at 72 hours after start intervention mL / Medical record,Incident of refractory shock at 28 days after enrollment percent / Medical record,Incidence of recurrent shock within 7 days at 7 days after start intervention percent / Medical record,Incidence of receiving renal replacement therapy at 72 hours after start intervention percent / Medical record,Ventilator-free days at 7 days after start intervention day / Medical record,Length of stay in the ICU at 28 days after enrollment day / Medical record,Length of stay in the hospital at 28 days after enrollment day / Medical record,Mortality rate at 7, 14, 28 day at 7, 14, 28 day after enrollment day / Medical record

Countries

Thailand

Contacts

Public ContactSasathorn Tharapoom

Division of pulmonary and critical care, Phramongkutklao hospital

selenegem@hotmail.com0850548065

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026